Breast Cancer FemaleNCT05730608
18F-FDG PET/CT Imaging for Breast Cancer
A study testing 18F-FDG PET/CT in people with Breast Cancer Female and Breast Cancer Recurrent, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Breast Cancer Recurrent
- What is being tested?
- 18F-FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 16 Feb 2023to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high risk primary or recurrent breast cancer
- Non pregnant women > 18 years
- Not receiving active treatment of other cancer types.
- Eastern Cooperative Oncology Group (ECOG) status 0-2.
Who cannot join
- Pregnant woman
- Males
- Age under 18
- Patients receiving active treatment for other cancers
- Poor general conditipon (ECOG 3 or higher)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Drammen Hospital - Vestre Viken HF
Drammen, N-3004
Harald Grut, MD, PHD
About this study
Official title: Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.
Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.
Read more
Objectives
Primary:
To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.
Secondary:
- Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
- Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
- Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
- Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
- Blood and tumor samples for molecular characterisation:
- Conditions
- Breast Cancer Female, Breast Cancer Recurrent
- Being tested
- 18F-FDG PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTOther
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| Primary breast cancer | Other | Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team. Receives: Other: 18F-FDG PET/CT |
| Recurrent breast cancer | Other | Patients with suspected or proven locoregional recurrent breast cancer. Receives: Other: 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in staging and/or management due to added 18F-FDG PET/CT scan
Percentage of the patients with change in staging and/or management
Measured: 5 years
Secondary outcomes (1)
Overall survival
Survival after 18F-FDG PET/CT scan
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start16 Feb 2023
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald Grut, MD, PHD, Principal investigator, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730608
- Sponsor's protocol ID
- 495077
- Status last verified
- May 2024
- First submitted
- 27 Jan 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD available by request (Harald Grut, harald.grut@gmail.com)
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)
- ClinicalTrials.gov ID
- NCT05730608
- Acronym / sponsor ID
- 495077
- Conditions
- Breast Cancer Female, Breast Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.
Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.
Objectives
Primary:
To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.
Secondary:
- Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
- Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
- Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
- Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
- Blood and tumor samples for molecular characterisation:
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary breast cancer | Other | Other: 18F-FDG PET/CTPatients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team. |
| Recurrent breast cancer | Other | Other: 18F-FDG PET/CTPatients with suspected or proven locoregional recurrent breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with high risk primary or recurrent breast cancer
- Non pregnant women > 18 years
- Not receiving active treatment of other cancer types.
- Eastern Cooperative Oncology Group (ECOG) status 0-2.
Key exclusion criteria (5 listed)
- Pregnant woman
- Males
- Age under 18
- Patients receiving active treatment for other cancers
- Poor general conditipon (ECOG 3 or higher)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CTIncluded breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy. | Other | Primary breast cancer, Recurrent breast cancer |
Primary outcome
Change in staging and/or management due to added 18F-FDG PET/CT scan
Time frame: 5 years
Percentage of the patients with change in staging and/or management
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Yes. IPD available by request (Harald Grut, harald.grut@gmail.com)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harald Grut, MD, PHD principal investigator
Vestre Viken Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET/CT in people with Breast Cancer Female and Breast Cancer Recurrent, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harald Grut, MD, PHD (004797108503, harald.grut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in staging and/or management due to added 18F-FDG PET/CT scan (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.